The Food and Drug Administration is pushing to withdraw a blood pressure drug that has been on the market for 14 years in spite of the manufacturer’s failure to submit evidence that it actually helps patients. The agency approved Shire Laboratories’ drug ProAmatine in 1996, based on promising early results in treating low blood pressure. But the company never conducted a mandatory follow-up study to actually prove the long-term benefits of the drug. While this drug may be safe if used as directed, the FDA’s failure to follow up and monitor the drug’s use is hard to understand. This appears to be the first time the FDA has threatened to pull a drug off the market due to missing follow-up data, even though it has long held that power.
For nearly 20 years, the FDA has granted accelerated approval to drugs based on so-called surrogate endpoints, or initial measures that suggest the drug will make real improvements in patient health. Drugmakers favor the program because it helps them get products to market sooner. But that doesn’t excuse the FDA’s actions or inactions.
Last fall the Government Accountability Office issued a report saying the FDA should do more to track whether drugs approved based on preliminary results actually live up to their promise. The report singled out ProAmatine as a particularly egregious example of missing follow-up data. The government watchdog said that ProAmatine has generated more than $257 million in sales even though “the clinical benefit of the drug has never been established.” According to the GAO, the FDA has never once pulled a drug off the market due to missing or unimpressive follow-up data. The GAO’s September 2009 report found that the FDA had requested 144 follow-up studies for drugs since 1992. Of those about 64% had been completed and more than one-third were still pending.
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